Selcuk University
Konya, Turkey (Türkiye)
NCT Number: NCT07793136
Aim: This randomized controlled trial aims to evaluate the effect of viewing personalized fetal images through a virtual reality (VR) headset during labor on childbirth comfort, maternal attachment, and perceived traumatic childbirth.
Methods: The study will include primiparous pregnant women at 28-32 weeks of gestation who voluntarily agree to participate and provide consent for fetal image recording. Participants will be randomly assigned to an intervention group or a control group. During labor, women in the intervention group will view their own personalized fetal images accompanied by fetal heart sounds through a VR headset for at least four minutes, with the option to continue viewing if desired. The control group will receive routine intrapartum care. Data will be collected using the Pregnant Woman Descriptive Information Form, Childbirth Comfort Questionnaire, Maternal Attachment Scale, and Traumatic Childbirth Perception Scale. Data will be analyzed using appropriate statistical methods, including independent-samples t-test, paired-samples t-test, and chi-square test, as appropriate. Statistical significance will be set at p < 0.05.
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Notify Me18 year–35 year
Female
Interventional
Not applicable
Konya, Turkey (Türkiye)
Aim:
This randomized controlled trial aims to evaluate the effect of viewing personalized fetal images through a virtual reality (VR) headset during labor on childbirth comfort, maternal attachment, and perceived traumatic childbirth.
Study Design and Participants:
The study will be conducted among primiparous pregnant women at 28-32 weeks of gestation who voluntarily agree to participate and provide informed consent for fetal image recording. Eligible participants will be randomly assigned to an intervention group or a control group.
Intervention:
During labor, participants assigned to the intervention group will view personalized images of their own fetus through a VR headset. The fetal images will be accompanied by fetal heart sounds. The VR intervention will be administered for a minimum of four minutes, and participants will have the option to continue viewing the personalized fetal images if they wish.
Control:
Participants assigned to the control group will receive routine intrapartum care without exposure to personalized fetal images through a VR headset.
Outcome Measures:
The primary outcomes will include childbirth comfort, maternal attachment, and perceived traumatic childbirth. Data will be collected using the Pregnant Woman Descriptive Information Form, Childbirth Comfort Questionnaire, Maternal Attachment Scale, and Traumatic Childbirth Perception Scale.
Statistical Analysis:
Data will be analyzed using appropriate statistical methods according to the distribution and characteristics of the variables. Independent-samples t-test, paired-samples t-test, and chi-square test may be used as appropriate. Statistical significance will be set at p < 0.05.
Ethical Considerations:
The study will be conducted in accordance with ethical principles and after obtaining approval from the relevant ethics committee. Written informed consent will be obtained from all participants before participation in the study.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in the intervention group will view personalized fetal ultrasound images recorded during routine antenatal ultrasonography using a virtual reality headset during the first stage of labor. The fetal ultrasound images will be accompanied by fetal heart sounds. The intervention will be administered when cervical dilatation reaches 4-9 cm in a quiet environment. Each viewing session will last for at least 4 minutes, and participants will be allowed to continue viewing according to their preference. The duration of VR exposure will be recorded for each participant.
Other names: Fetal Images Through Virtual Reality
Time frame: 30 days postpartum.
Maternal attachment will be assessed using the Maternal Attachment Scale. Higher scores indicate stronger maternal attachment.
Time frame: During active labor, at 8 cm cervical dilatation.
Childbirth comfort will be assessed using the Childbirth Comfort Questionnaire (CCQ), a 9-item, 5-point Likert-type scale consisting of physical, psychospiritual, and environmental comfort subscales. Total scores range from 9 to 45, with higher scores indicating greater childbirth comfort.
Selcuk University
Other
Effect of Viewing Personalized Fetal Images Through Virtual Reality During Labor on Childbirth Comfort, Maternal Attachment, and Perceived Traumatic Childbirth: A Randomized Controlled Trial
Acronym: FITVRDL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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